Method of making textured surface prosthesis implants

Abstract

A surgical prosthesis is disclosed having a textured exterior surface formed of non-absorbent material substantially free of pores and interstices. The invented device is usable for mammary and other implants. Various methods of manufacturing the device are also disclosed.

We claim: 
     
       1. A process for making a textured surgical implant comprising: providing a smooth surface prosthesis shell having an exterior surface;   disposing said shell on a substantially round disc-shaped mounting means, said mounting means having a first side and a second side, and wherein said shell is substantially disposed on said first side of said disk;   disposing a formable, biocompatible material over said shell at least a portion of said exterior surface;   providing a texturizing means;   disposing said texturizing means over said formable, biocompatible material thereby imprinting said material to form a textured surface thereon;   removing said texturing means from said textured material;   curing said textured material to form a textured shell;   patching said shell;   filling said shell with a filler material; and   patching said filled shell to retain said filler material in said shell.   
     
     
       2. The process of claim 1 wherein said texturizing means is disposed over said material only on said first side. 
     
     
       3. The process of claim 1 wherein said material is disposed on said shell on said first side and said second side of said disk and said texturing means comprises two texturing means, one disposed on said material on each side of said disk. 
     
     
       4. The process of any of claim 1 wherein after said texturing means is disposed on said material, said shell is compressed between a pair of platens. 
     
     
       5. The process of claim 4 wherein said platens are at ambient temperature. 
     
     
       6. The process of claim 4 wherein at least one of said platens is at an elevated temperature. 
     
     
       7. The process of claim 1 wherein said formable, biocompatible material comprises silicone. 
     
     
       8. The process of claim 7 wherein said silicone comprises silicone sheeting. 
     
     
       9. The process of claim 1 wherein said texturing means comprises foam. 
     
     
       10. The process of claim 9 wherein said foam comprises reticulated foam. 
     
     
       11. The process of claim 1 wherein said texturizing means comprises a texturized plate. 
     
     
       12. The process of claim 1 wherein said texturizing means comprises a screen. 
     
     
       13. The process of claim 1 wherein said patch comprises texturized material. 
     
     
       14. The process of claim 1 wherein said patching step comprises the steps of: providing a patch of partially vulcanized silicone;   disposing thereover a texturizing means;   inserting said texturized patch in a patch hole of said shell with the texturized portion thereof facing outward;   adhering said patch to said shell with silicone; and   curing the patched shell.   
     
     
       15. A process for making a texturized surgical implant comprising the steps of: providing a mounting means formed substantially in the shape of the implant, said mounting means having disposed on its exterior surface a textured surface;   coating said mounting means with a biocompatible formable material capable of adhering to an implant shell;   disposing said shell over said coated mounting means;   allowing said material to adhere to said shell;   curing said shell and material;   removing said implant shell and material from said mounting means;   reversing said shell inside out so that said material is disposed on the exterior thereof;   patching said shell; and   filling said shell with filling material; and   patching said filled shell.   
     
     
       16. A process for making a textured surgical implant comprising: providing a smooth surface prosthesis shell having an exterior surface;   stretching said shell on a substantially round disc-shaped mounting means, said mounting means having a first side and a second side, whereby said shell is substantially disposed on said first side of said mounting means;   layering unvulcanized or partially vulcanized silicone over at least a portion of said exterior surface of said shell;   providing a reticulated foam as a texturizing means;   disposing said reticulated foam over said silicone;   compressing said reticulated foam and said silicone layered shell together thereby texturizing said silicone layer;   removing said texturing means from said textured layer;   curing said unvulcanized or partially vulcanized silicone to form a texturized shell;   patching said shell;   filling said shell with a filler material; and   patching said filled shell to retain said filler material in said shell.   
     
     
       17. The process of claim 16 wherein said silicone is disposed on said shell on said first side and said second side of said mounting means and said texturing means comprises two pieces of reticulated foam, one disposed on each side of said disk, whereby the shell on both sides of said disk is texturized. 
     
     
       18. The process of claim 16 wherein said compressing step is performed by compressing said shell between a pair of platens. 
     
     
       19. The process of claim 18 wherein said platens are at ambient temperature. 
     
     
       20. The process of claim 18 wherein at least one of said platens is at an elevated temperature.